Field Safety Notice: 27 to 30 August 2019
List of field safety notices (FSNs) from medical device manufacturers from 27 to 30 August 2019.
Overview
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
MHRA publishes the following for information only.
If you have a question about a particular FSN contact the manufacturer.
Latest FSNs
View the latest
AGFA: DR 800
VR0000638
X Ray, genera
MHRA reference:
Becton Dickinson: BD FACSLyric鈩� Flow Cytometer
August 2019
IVDs, cytopathology & histopathology
Model: BD FACSLyric鈩� Flow Cytometer
MHRA reference:
Edwards Life Sciences: IntraClude Intra-Aortic Occlusion Device
FCA 125
Vascular cannula and catheters
Model: ICF100
MHRA reference:
GE: Giraffe Bedded Warmers, Panda iRes Warmers
32067-A
Infant incubators
MHRA reference:
Medicina: Medicina IV Syringe
22 August 2019
Injection devices
Model: IVS03
MHRA reference:
Medline International: Towel, surgical
14 August 2019
Basic dressings, absorbents, swabs, procedure packs
MHRA reference:
Medtronic: StealthStation Cranial 3.x Software; StealthStation S8 Cranial Software
August 2019
Surgical navigation system and accessories
MHRA reference:
Pivotal Health Solutions: Epidural Positioning Device
27 August 2019
Injection devices
Model: EPD Package 2
MHRA reference:
Radiometer: AQURE system
29 August 2019
IVDs, extra laboratory testing
Model: 933-599
MHRA reference:
Radiometer: TCM5 FLEX/TCM5 BASIC
FAN 915-375
Diagnostic measurement and monitoring
MHRA reference:
Rapid Medical:Endorectal Coils
16 August 2019
Magnetic resonance, equipment & accessories
Model: 01924, 01947, 01899, 01900, 01752
MHRA reference:
Richardson Healthcare: C-Sorb
27 August 2019
Basic dressings, absorbents, swabs, procedure packs
MHRA reference:
Roche: ALB2, BILT3
August 2019
IVDs, clinical chemistry
MHRA reference:
Signus Medizintechnik: RABEA PEEK, zervikaler Cage gewinkelt 6x12x14mm 5掳
8 August 2019
Spinal implants
MHRA reference: